NCT03783442 · ADVERSE EVENTS

Adverse events

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2025-07-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All-cause mortality was assessed from randomization until the end of study, maximum time on study was 63.6 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 63.5 months.
Other-event reporting threshold: 3%

All-cause mortality was assessed in all randomized participants; adverse events were assessed in all participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tislelizumab + Chemotherapy Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	160 / 324	321 / 324	252 / 326
Placebo + Chemotherapy Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	128 / 321	314 / 321	268 / 323

Group identifiers: EG000: Tislelizumab + Chemotherapy · EG001: Placebo + Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
8
group Id
EG001
num Affected
6
num At Risk
321
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
324
num Events
5
group Id
EG001
num Affected
5
num At Risk
321
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
4
num At Risk
321
num Events
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
321
num Events
2
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
7
num At Risk
321
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
321
num Events
0
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
321
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
2
term
Prinzmetal angina

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
193
num At Risk
324
num Events
343
group Id
EG001
num Affected
180
num At Risk
321
num Events
322
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
15
group Id
EG001
num Affected
3
num At Risk
321
num Events
3
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
34
num At Risk
324
num Events
86
group Id
EG001
num Affected
28
num At Risk
321
num Events
87
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
54
num At Risk
324
num Events
122
group Id
EG001
num Affected
45
num At Risk
321
num Events
148
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
29
num At Risk
324
num Events
43
group Id
EG001
num Affected
24
num At Risk
321
num Events
36
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
33
num At Risk
324
num Events
35
group Id
EG001
num Affected
15
num At Risk
321
num Events
21
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
17
num At Risk
324
num Events
29
group Id
EG001
num Affected
14
num At Risk
321
num Events
19
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
25
num At Risk
324
num Events
26
group Id
EG001
num Affected
13
num At Risk
321
num Events
17
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
15
num At Risk
324
num Events
19
group Id
EG001
num Affected
13
num At Risk
321
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
102
num At Risk
324
num Events
141
group Id
EG001
num Affected
101
num At Risk
321
num Events
130
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
88
num At Risk
324
num Events
124
group Id
EG001
num Affected
76
num At Risk
321
num Events
118
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
21
group Id
EG001
num Affected
8
num At Risk
321
num Events
8
term
Dyspepsia

Complete source fields

description

All-cause mortality was assessed in all randomized participants; adverse events were assessed in all participants who received at least 1 dose of study drug.

event Groups

deaths Num Affected
252
deaths Num At Risk
326
description
Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
id
EG000
other Num Affected
321
other Num At Risk
324
serious Num Affected
160
serious Num At Risk
324
title
Tislelizumab + Chemotherapy
deaths Num Affected
268
deaths Num At Risk
323
description
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
id
EG001
other Num Affected
314
other Num At Risk
321
serious Num Affected
128
serious Num At Risk
321
title
Placebo + Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
193
num At Risk
324
num Events
343
group Id
EG001
num Affected
180
num At Risk
321
num Events
322
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
15
group Id
EG001
num Affected
3
num At Risk
321
num Events
3
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
34
num At Risk
324
num Events
86
group Id
EG001
num Affected
28
num At Risk
321
num Events
87
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
54
num At Risk
324
num Events
122
group Id
EG001
num Affected
45
num At Risk
321
num Events
148
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
29
num At Risk
324
num Events
43
group Id
EG001
num Affected
24
num At Risk
321
num Events
36
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
33
num At Risk
324
num Events
35
group Id
EG001
num Affected
15
num At Risk
321
num Events
21
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
17
num At Risk
324
num Events
29
group Id
EG001
num Affected
14
num At Risk
321
num Events
19
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
25
num At Risk
324
num Events
26
group Id
EG001
num Affected
13
num At Risk
321
num Events
17
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
15
num At Risk
324
num Events
19
group Id
EG001
num Affected
13
num At Risk
321
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
102
num At Risk
324
num Events
141
group Id
EG001
num Affected
101
num At Risk
321
num Events
130
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
88
num At Risk
324
num Events
124
group Id
EG001
num Affected
76
num At Risk
321
num Events
118
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
21
group Id
EG001
num Affected
8
num At Risk
321
num Events
8
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
8
group Id
EG001
num Affected
6
num At Risk
321
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
324
num Events
5
group Id
EG001
num Affected
5
num At Risk
321
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
4
num At Risk
321
num Events
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
321
num Events
2
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
7
num At Risk
321
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
321
num Events
0
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
321
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
321
num Events
2
term
Prinzmetal angina

time Frame

All-cause mortality was assessed from randomization until the end of study, maximum time on study was 63.6 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 63.5 months.

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